Devices

CTI has significant experience in device and in vitro diagnostic (IVD) development across a multiple therapeutic areas. We have also worked on multiple programs involving combinations of drug /device and cell and gene therapy/device products. Our team has expertise in regulatory submissions including 510(K)s, investigational device exemptions (IDEs), and Premarket Approval Applications (PMAs). We have provided regulatory strategy consulting, clinical trial design and execution, as well as Clinical Evaluation Report (CER) development for our sponsors with device programs. With a full suite of service offerings, including Health Outcomes and Economics, we are often a first choice partner for sponsors with device development support needs.